=SAGE Therapeutics (SAGE): top-line results from its Phase 3 STATUS Trial

SAGE Therapeutics reports top-line results from its Phase 3 STATUS Trial of brexanolone (SAGE-547) in the treatment super-refractory status epilepticus; study did not meet primary endpoint

The study did not meet the primary endpoint, comparing success in weaning of third-line agents and resolution of potentially life-threatening status epilepticus with brexanolone vs. placebo (43.9% vs 42.4%; p=0.8775) when added to standard-of-care.

• Demographics and baseline characteristics were well-balanced between treatment groups in the study. Due to the severity and complexity of their underlying medical conditions, serious adverse events commonly occur in patients with SRSE and were similar in frequency and type between the two treatment groups. SRSE, a life-threatening persistent state of seizure that does not respond to first-, second- or third-line treatments, is a neurological emergency that may cause death or life-altering outcomes. There are no treatments for SRSE currently approved by the U.S. Food and Drug Administration (FDA).
• "Although we did not meet the primary endpoint, this first-ever trial in a highly variable and complex patient population confirms that research in a critical care unit is possible and deepens our understanding of GABA mechanisms and their effect on brain circuitry. As we continue examining data from the STATUS Trial in the coming weeks, I'm hopeful this information will inform current treatments, and aid in the development of future treatments for patients with SRSE."